Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain

Neck Pain Clinical Trial

Official title:

Telerehabilitation Based Pain Neuroscience Education on Patients With Non-specific Chronic Neck Pain: A Double-Blinded Randomized Controlled Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05249517
• Other study ID #: DokuzEU_AO
• Status: Completed
• Phase: N/A
• Start date: February 1, 2022
• Est. completion date: December 8, 2022

Study information

• Verified date: February 2023
• Source: Dokuz Eylul University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

In this study, the effects of 6-week telerehabilitation-based Pain Neuroscience Education and exercise training in participants with Non-specific Chronic Neck Pain will be investigated.

Description:

Neck pain is a general health problem that is very common in society and affects daily life activities by causing disability. Non-specific chronic neck pain is defined as "continuous neck pain that persists for 12 weeks or longer beyond the healing process without any known specific pathology. Chronic pain is considered to be a complex problem in which cognitive and emotional factors, as well as biological factors, significantly affect the perception of pain. In the last decade, a patient education model that educates people about the neurobiology and neurophysiology of pain has been recognized as an intriguing approach to the management of chronic pain. Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain. In the literature, there is evidence supporting the use of PNE in reducing pain and disability and overcoming the psychosocial factors of chronic pain. While the Covid-19 pandemic has made telerehabilitation applications widespread, it has also shown us its necessity, but until now, no study in which Pain Neuroscience Education was carried out with the telerehabilitation method has been found in the literature. This study aimed to perform Pain Neuroscience Education with the telerehabilitation method on patients with non-specific chronic neck pain and to examine the effects on pain-related factors, disability, and quality of life. It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood. In this study, in addition to telerehabilitation-based PNE, progressive submaximal exercise program will also be given to the participants through telerehabilitation.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: December 8, 2022
• Est. primary completion date: September 8, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 55 Years

Eligibility

Inclusion Criteria:

• Being between the ages of 18-55
• History of neck pain lasting at least three months
• Agreeing to participate in the study
• Being able to read and write Turkish
• Having a computer or tablet and an active internet connection at home
• To be able to use a computer, tablet and internet at a level to participate in video conference or to have a relative who can help in this regard.

Exclusion Criteria:

• History of spinal surgery
• Traumatic cervical injuries
• Serious comorbidities (neurological, neuromuscular, cardiological, psychiatric)
• Tumor conditions
• Having vision and hearing problems
• Cognitive problems
• Receiving physiotherapy for neck and/or low back pain in the last 6 months

Related Conditions & MeSH terms

• Neck Pain

Intervention

Other:
• Pain Neuroscience Education
Pain Neuroscience Education (PNE) is a patient education approach that explains in detail the neurobiology, neurophysiology of pain, and the processing of pain by the nervous system in the management of chronic pain.
• Progressive submaximal exercise program
It has been shown that the long-term results of the use of PNE in addition to physiotherapy are more effective in reducing pain and disability. It has been reported that progressive submaximal exercise program including cervicothoracic strengthening, endurance, flexibility, and coordination exercises has positive effects on chronic neck pain, related disability, quality of life and mood.

Locations

Country	Name	City	State
Turkey	School of Physical Therapy and Rehabilitation, Dokuz Eylül University	Izmir

Sponsors (1)

Lead Sponsor	Collaborator
Dokuz Eylul University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Numeric Pain Rating Scale	Numerical Pain Rating Scale will be used to evaluate the severity of pain. Participants will be asked to determine the number that best describes their pain, with 0 = no pain and 10 = unbearable pain, on a scale divided into numbers between 0 and 10 for the severity of pain they feel during rest and activity.	6 weeks
Primary	Neurophysiology of Pain Questionnaire	The Neurophysiology of Pain Questionnaire will be used to assess pain information. The Pain Neurophysiology Questionnaire was developed as a method of assessing whether healthcare professionals and patients understand the pain and its underlying complex neurophysiological mechanisms. Scoring is in the range of 0-13 points according to the number of correct answers given. Higher scores mean better pain knowledge. It is widely used by clinicians to monitor information exchange in pain education interventions.	6 weeks
Secondary	Neck Disability Index	The level of disability associated with the neck pain will be evaluated with the Neck Disability Index. The index consists of 10 sections that include pain sensitivity, personal care, weight lifting, reading, headaches, concentration, work/job, driving, sleep, and social activities. Each item is scored between zero (no disability) and five (total disability). The maximum score is therefore 50. Higher scores indicate having more disabilities.	6 weeks
Secondary	Tampa Scale of Kinesiophobia	Tampa Kinesiophobia Scale will be used to evaluate kinesiophobia, which is an anxiety state that develops against activity and physical movement due to pain and fear of re-injury. The scale has 17 pain statements, and the patient selected her agreement for each question using a 4-point scale. The maximum score is 68. Higher score indicates having more fear of movement.	6 weeks
Secondary	Pain Catastrophising Scale	Pain Catastrophising Scale will be used to determine the degree of pain catastrophising felt by individuals with pain. Pain Catastrophising Scale is a self-reported scale with 13 statements, where the patient ranks the affirmations between 0 "minimal" to 4 "very intense." The calculation of the final score is based on 3 subdomains of the scale and scores closer to 52 indicate worse results.	6 weeks
Secondary	World Health Organization Quality of Life Scale-Short Form (WHOQOL-Bref)	The Turkish version of the World Health Organization Quality of Life Scale Short Form (WHOQOL-BREF) will be used to assess the quality of life. The scale consists of 4 quality of life domains: physical, psychological, social relations and environmental. It has 27 statements and the maximum score is 135. Higher score means higher quality of life.	6 weeks